ArticleDrug safety2014
Electrocardiographic data quality in thorough QT/QTc studies.
Article in Drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Observational
- Sources of QTc variability: Implications for effective ECG monitoring in clinical practice.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2020Review
- Sex and race differences in J-Tend, J-Tpeak, and Tpeak-Tend intervals.Scientific reports · 2019Article
- Importance of QT/RR hysteresis correction in studies of drug-induced QTc interval changes.Journal of pharmacokinetics and pharmacodynamics · 2018Article
- Universal Correction for QT/RR Hysteresis.Drug safety · 2016Article
- Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.Drug safety · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
backgroundMost drugs with systemic bioavailability have to undergo a thorough QT (TQT) study, which includes a pharmacologic positive control. A set of QTc-quality tests was recently proposed with the possible aim of removing the need for a positive control.
objectiveWe evaluated the influence of QT measurement and QTc computation methodology on the proposed QTc-quality tests.
methodsThe baseline ECG waveforms and fiducial points were retrieved from 34 crossover TQT studies that had full-day baseline ECGs prior to each study period. The QT measurement methodology and recorder type were retrieved from study reports. The influence of QTc computation methodology was investigated by applying the pattern-matching technique and/or using the 10-s average heart rate.
resultsThere were no statistical differences in any QTc-quality test values between studies using continuous or 10-s bedside recordings and, in a subset of the quality test, an increase of data quality for semi-automatically read studies compared with those manually read (p < 0.01). There was a significant improvement (p < 0.01) in all the QTc-quality test values for QTc measurements obtained by using pattern matching with or without 10-s average heart rate in comparison to the original QTc measurements.
conclusionThe findings suggest that QTc quality is mostly driven by the QTc measurement methodology rather than other study-related factors.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.